Nitric oxide inhalation therapy for infants with bronchiolitis

Abstract

The present invention provides a method for treating bronchiolitis in an infant in need thereof, wherein the method comprises repeatedly administering to the infant a gas mixture comprising nitric oxide at a concentration from about 144 to about 176 ppm for a first period of time, followed by a gas mixture containing no nitric oxide for a second period of time, wherein the administration is repeated for a time sufficient to: a) reduce the length of time of hospitalization required to achieve oxygen saturation greater than or equal to 92% in room air; b) reduce the length of time of hospitalization required to achieve a clinical score of less than or equal to 5; c) reduce the length of time of hospitalization required to be discharged; or d) any combination thereof, as compared to an infant that is not subjected to the repeated administration of nitric oxide.

What is claimed is: 
     
         1 . A method for treating bronchiolitis in an infant in need thereof, wherein the wherein the method comprises repeatedly administering to the infant a gas mixture comprising nitric oxide at a concentration from about 144 to about 176 ppm for a first period of time, followed by a gas mixture containing no nitric oxide for a second period of time,
 wherein the administration is repeated for a time sufficient to:
 a) reduce the length of time of hospitalization required to achieve oxygen saturation greater than or equal to 92% in room air, compared an infant that is not subjected to the repeated administration of nitric oxide; 
 b) reduce the length of time of hospitalization required to achieve a clinical score of less than or equal to 5, compared an infant that is not subjected to the repeated administration of nitric oxide; 
 c) reduce the length of time of hospitalization required to be discharged, compared an infant that is not subjected to the repeated administration of nitric oxide; or 
 d) any combination thereof. 
   
     
     
         2 . The method according to  claim 1 , wherein the first time period is 30 minutes and the second time period is from about 3 to about 5 hours. 
     
     
         3 . The method according to  claim 1 , wherein the administration is repeated six times per day. 
     
     
         4 . The method according to  claim 1 , wherein the nitric oxide is repeatedly administered for a period of time from about one day to three weeks. 
     
     
         5 . The method of  claim 4 , wherein the nitric oxide is repeatedly administered for five days. 
     
     
         6 . The method of  claim 1 , wherein the method further comprises monitoring at least one on-site oximetric parameter in the infant, the on-site parameter being selected from the group consisting of: oxyhemoglobin saturation (SpO 2 ); methemoglobin (SpMet); perfusion index (PI); respiration rate (RRa); oxyhemoglobin saturation (SpO2); total hemoglobin (SpHb); carboxyhemoglobin (SpCO); methemoglobin (SpMet); oxygen content (SpOC); and pleth variability index (PVI). 
     
     
         7 . The method of  claim 1 , wherein the method further comprises monitoring at least one additional on-site spirometric parameter in the infant, the at least one additional on-site parameter being selected from the group consisting of: forced expiratory volume (FEV1); maximum mid-expiratory flow (MMEF); diffusing capacity of the lung for carbon monoxide (DLCO); forced vital capacity (FVC); total lung capacity (TLC); and residual volume (RV). 
     
     
         8 . The method of  claim 1 , wherein the method further comprises monitoring at least one on-site parameter in the gas mixture inhaled by the infant, the on-site parameter being selected from the group consisting of: end tidal CO 2  (ETCO 2 ); nitrogen dioxide (NO 2 ), nitric oxide (NO); serum nitrite/nitrate; and fraction of inspired oxygen (FiO 2 ). 
     
     
         9 . The method of  claim 1 , wherein the method further comprises monitoring at least one off-site bodily fluid parameter in the infant, the parameter being selected from the group consisting of: a bacterial and/or fungal load; urine nitrite; blood methemoglobin; blood pH; a coagulation factor; blood hemoglobin; hematocrit ratio; red blood cell count; white blood cell count; platelet count; vascular endothelial activation factor; renal function; an electrolyte; a pregnancy hormone; serum creatinine; and liver function.